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Intro VO:Welcome to the Ideas Lab Predictor Podcast from the University of Birmingham. In each edition we hear from an expert in a different field, who gives us insider information on key trends, upcoming events, and what they think the near future holds.

Lucy: You’ve just published some major research which might have a big impact on women’s healthcare.

Janesh: Yes, this is a very large, in fact it represents the largest trial in the world, that has looked at medical therapies that are used for the treatment of heavy periods, so women who come with a significant quality of life impact having had heavy periods for usually many years and it has a bearing on several of their factors in their life – work, social, family, sexual – these factors have all been a major impact. Women with this condition are now able to access, with the results from the study, access to very good treatments now available by their general practitioner.

Lucy: So this is about the Mirena coil.

Janesh: Yes. This is, the study looked at randomising women, so allocating them either to the Mirena coil, or other treatments that either you take as tablets, so Tranexamic Acid, Mefenamic Acid, the combined oral contraceptive pill or injections of progesterones versus the Mirena. So the idea was really to see which one of those two types is going to be the most effective. We found that outstandingly better results were achieved with the Mirena coil and that is sustained over a two year follow up period which is the first time point that we have reported on in our paper in the New England Journal of Medicine.

Lucy: So you’ve been looking at it over this two year stretch of time.

Janesh: Over a two year period, correct. So we’ve recruited 571 women, all from general practice regions within the West Midlands, East Midlands and further apart and these women were basically presented as general practice patients who said ‘I’ve got heavy periods’ and we then recruited them into those two arms.

Lucy: So they were all women whose lives had been made a misery by suffering with heavy periods.

Janesh: Yes. So the idea was really to assess their quality of life and we used a disease specific heavy periods menstrual quality of life instrument and we showed that the change that they saw at 6 months, 12 months and two years was dramatically better, significantly better, with the Mirena coil compared to the oral or standard usual treatment arm.

Lucy: The Mirena coil was already licensed for this kind of use.

Janesh: Yes.

Lucy: So is it just the case that it wasn’t being used very much in this way? People didn’t really know that it could do this?

Janesh: Yes. It was licensed for its use, it is licensed for use as a contraceptive as well, but I think what was happening is that women were not being necessarily treated in primary care so the GPs were not necessarily using it in an extensive manner because they thought that the patients need to be referred for assessment first before the Mirena coil should be used. This trial should say that if you’ve got a woman that comes to you at a point of contact, by examining her and she’s found to be a normal uterus and she has no other factors that shouldn’t exclude her from treatment. That GP can now treat that patient and the first line choice of treatment would be the Mirena coil.

Lucy: So that means that the woman wouldn’t have to be referred to hospital, she wouldn’t have to see a consultant, she could be treated in the GP surgery.

Janesh: Correct. Exactly right.

Lucy: Quite a revolution.

Janesh: Yes, because it means that the first point of contact, without all the anxiety having to go to the hospital -

Lucy: And the time it takes.

Janesh: And the time of taking time off work, she is now being able to treat in her local practice. Now it may be that that particular GP doesn’t have the skills to fit that coil in but there are systems put into place in general practice where they can refer to enhanced centres where there are GPs skilled in fitting coils so there will be areas within the general practice system that will allow that particular patient to be referred nearby, have the coil fitted and it’s going to have a dramatic improvement in her quality of life, just by potentially that one visit.

Lucy: Amazing. So saving time, saving money and giving a solution to a patient a lot more quickly.

Janesh: Yes, that’s right and we’ve shown that in fact – and other studies have actually shown – that if you refer patients to hospital they potentially undergo unnecessary treatments. So this will also avoid that.

Lucy: So if you’re a patient out there, you’re suffering from heavy periods, the message is you can go to your doctor and you can talk about this.

Janesh: Yes. Talk to your doctor about it. Your doctor should be able to examine you. If there are no obvious reasons like large fibroids or anything that is untoward in the history that suggests that you need to be referred to the hospital, then potentially your treatment might be having a Mirena coil fitted as first choice. Now remember the Mirena coil is a contraceptive so this is where women don’t want to try for pregnancy in the near future. But our study even showed that the other arm, where they were given Tranexamic Acid or [Mefenamic Acid], those treatments are effective treatments for heavy periods, but not as effective as the Mirena coil. So if you don’t want to have contraception and are wanting to have a pregnancy then use of Tranexamic Acid and [Mefenamic Acid] is the alternative. So the trial has actually shown benefit in two different ways. So it's not the risk that in the future I’m not going to be able to get pregnant because I have to have a Mirena coil in for my heavy periods. You can still have an effective method of treatment and still achieve a pregnancy if desired.

Lucy: So it’s giving women a choice.

Janesh: Yes, it’s giving them a choice either way, which is very good.

Lucy: Well thank you very much for sharing all that information with us, Janesh. I know there's quite a lot of information available on the website for people who are interested in finding out more about this and probably it will be quite a lot of people I imagine that this could make a difference to and I believe that the NICE guidelines may actually change because of this research.

Janesh: Yes. We would hope that the NICE guidelines will now say that the first choice, the first line choice for treatment of heavy periods in primary care should be the Mirena coil and it I think will be a benefit to further the research when we follow up our patients for five years follow up, to see what effect these treatments have had over a longer period of time and I think interestingly, more data will come out at five years and if not at ten years to see what happens to these patients over the longer period. Most studies have done things usually between six and twelve months follow up, so our study not only represents the largest number of patients we’ve recruited, but we’ve recruited them as currently the longest two year follow up but I think interesting data from whether surgical interventions are reduced at five years and possibly at ten years and if that gets shown then it would be a significant impact on patients’ not only quality of life but need for surgical intervention.

Lucy: Well, Professor Janesh Gupta, thank you very much for taking the time to tell us about this research. I know you’ve got to rush off and deliver some babies now, the other part of your job!

Janesh: That’s fine, thank you very much.

Lucy: Thank you.

Outro VO:This podcast and others in the series are available on the Ideas Lab website: www.ideaslabuk.com. On the website, you can find out how to e-mail us with comments, questions or suggestions for future topics for the podcast. There's also information on the free support Ideas Lab has to offer to TV and radio producers, new media producers and journalists. The interviewer for the Ideas Lab Predictor Podcast was Lucy Vernall and the producer was Sam Walter.